Keeping an eye on changes is part of everyday regulatory life.
A test according to standard XY is a Polaroid, a snapshot of the current state of my product or a partial aspect of my value proposition.
As soon as the declaration of conformity has been signed, the market surveillance processes begin in the form of Post Market Surveillance (PMS) and Post Market Clinical Follow Up (PMCF). In our article ‘PMS according to MDR’, we take a look at market surveillance using an example.
These two terms are very familiar to you. There is a lot of discipline and organisation behind both terms. Requirements, materials, rules, prohibitions, guidelines, gold standards, norms, etc. change depending on the size of the company, the degree of innovation of the products and the internal and external knowledge gained.
The company's own complaint analyses and customer feedback are not ignored. Regulatory affairs managers have no choice but to regularly search the relevant databases. Larger companies can make use of automated or semi-automated retrievals. This solution is out of the question for many due to high set-up and operating costs. Alternatively, you can subscribe to standards tickers and other newsletters that need to be analysed. We also offer a standards segment that can at least make the search for standards a little easier for you, as we customise it editorially for our clientele. In response to several customer requests, we have now also added the evaluation of the ISO database.
- Whichever route you take, it all starts with a defined process, a plan:
- Which steps are to be carried out when and how?
- Check and determine whether PMS and PMCF can perhaps be completed in one step.
- Define search locations and search criteria so that auditors can understand and approve your work.
However, if there is a lack of time or expertise, there is still the option of outsourcing. In addition to the newsletter mentioned above, we also offer our help in this area. Get in touch with us.
(1 Rating(s), average: 5.00 out of 5)
Loading...
